Kornimate/medical-research-clean huggingface dataset:
observational study of patients receiving dupixent® for atopic dermatitis (ad)

Conditions: Dermatitis Atopic

Summary: primary objective: to characterize the patients who receive dupixent® (dupilumab) for ad in a real-world setting, with respect to their medical history, socio-demographic and disease characteristics, and prior and concomitant treatments of ad secondary objectives: * to characterize real-world use patterns of dupixent® for ad (eg, used regimens, reason for initiation of new treatments, concomitant therapies, treatment durations and reasons for discontinuation and/or switching) * to assess the long-term effectiveness of dupixent® in ad patients in a real-world setting * to assess comorbid atopic conditions and effects of treatment in comorbid atopic conditions in patients who receive dupixent® for ad * to collect safety data on study participants

participants enrolled in the study will be followed for 5 years.

Eligibility criteria:
inclusion criteria: * male or female, 12 years or older at the baseline visit. note: adolescent participants (at least 12 years old, but less than 18 years) are eligible only after dupixent® receives the respective country's regulatory approval for use in this age group; * initiating treatment with dupixent® for ad according to the country-specific prescribing information. note: participants may be eligible if they have already initiated treatment with dupixent® for ad within 6 months before their enrollment in the registry, provided that all core baseline data required (eczema area and severity index \[easi\], scoring of atopic dermatitis \[scorad\], body surface area \[of ad involvement\] \[bsa\], patient-oriented eczema measure \[poem\], and dermatology life quality index \[dlqi\]) by the registry protocol were captured at the time of initiating dupixent® treatment and are available for entry in the registry database * able to understand and complete study-related questionnaires * provide signed informed consent or parental/legally acceptable representative consent and/or patient assent where applicable exclusion criteria: * participants who have a contraindication to the drug according to the country-specific prescribing information label * any condition that, in the opinion of the investigator, may interfere with patient's ability to participate in the study, such as short life expectancy, substance abuse, severe cognitive impairment, or other co-morbidities that can predictably prevent the participant patient from adequately completing the schedule of visits and assessments * patients currently participating in any interventional clinical trial which modifies patient care * prior use of dupixent® within 6 months of the screening visit, or within 6 months of the baseline visit if screening and baseline occur on the same day the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
neurostimulation for sleep disordered breathing

Conditions: Sleep Disordered Breathing (SDB); Sleep Apnea

Summary: this is a first in human study to determine if the lunair alpha system is safe and effective for treating moderate to severe sleep disordered breathing.


Eligibility criteria:
inclusion criteria: * subject does not tolerate, not compliant to or have access to alternative sleep disordered breathing treatments * subject has moderate to severe sleep disordered breathing as diagnosed by psg exclusion criteria: * subject is taking opioids, narcotics, sleep or psychotic medications or supplements that may alter consciousness, the pattern of respiration, sleep architecture, or with known effect on sleep-wake function or alertness. * any reason for which, in the judgment of the investigator, the subject is considered to be a poor study candidate * subject has previous upper respiratory tract (urt) surgery or procedure (e.g., uvula, soft palate or tonsils) within 60 days prior to screening psg. * subject has a need for chronic supplemental oxygen therapy for any reason * subject has other sleep disorders or sleep hygiene behaviors that confound functional assessments of sleepiness * subject has severe chronic kidney disease * subject exhibits ongoing misuse of alcohol, tobacco, caffeine, or recreational drugs that would impact either the results of or the participation in a sleep study. * subject conducts work or regular activities requiring vigilance * subject is unwilling or unable to refrain from consumption of alcoholic beverages for 24 hours prior to the start of each psg study. * subject is unwilling or unable to refrain from sleep disordered breathing treatments or devices * subject has an active systemic infection at time of implant. * subject has clinical evidence of immunodeficiency. * any condition likely to require future mri or diathermy * subject is pregnant * subject has a severe nasal obstruction that could restrict airflow * subject has any trauma to the upper airway * subject has previous surgical resection, prior or current radiation therapy for cancer or congenital malformations in the larynx, tongue, or throat.
maturation of arteriovenous fistula with automated sonography assessments trial

Conditions: Diabetes; End Stage Renal Disease

Summary: this is a prospective, multi-center, two-arm, randomized trial to quantify the performance of the echomark®/echosure® system for avf diagnostic ultrasound when used under a protocol of biweekly use for assessing fistula maturation and reducing time to clinical maturation.


Eligibility criteria:
inclusion criteria: * males or non-pregnant, non-breastfeeding females ≥ 18 years of age but \< 85 years of age at the time of informed consent. * subject is able and willing to provide written informed consent prior to receiving any non-standard of care, protocol specific procedures. * subject is willing and capable of complying with all required follow-up visits. * subject and/or care team agree that the distance and transportation resources from the patient's home to the clinic are reasonable for study participation and compliance. * subject has an estimated life expectancy \> 18 months. * subject is ambulatory (cane or walker are acceptable). * ckd stage 5 (egfr less than 10) or esrd subjects presenting for upper arm autologous arteriovenous fistula creation that is not transposed for hemodialysis access. * subjects who are currently on dialysis through a cvc or who imminently require dialysis (gfr \<10). * vein diameter ≥ 2.5 mm at the antecubital fossa per vein mapping. * artery diameter ≥ 2.5 mm per vein mapping. * subject is not participating in another investigational clinical trial that has not met its primary end point. participation in post-market registry is acceptable. exclusion criteria: * ckd stage 1-4 or subjects that do not require upper arm autologous arteriovenous fistula creation for hemodialysis access. * subject has history of steal syndrome. * subject who is immunocompromised or immunosuppressed. * subject has had three previous failed av fistulae for hemodialysis access. * subjects expecting to undergo major surgery within 60 days from the echomark implantation. * known or suspected active infection on the day of the index procedure. * subjects who had infection(s) in the 30-day window prior to echomark placement to reduce the likelihood of partially treated infections that can seed the device and fistula. * subjects with diagnosed bleeding disorder, thrombocytopenia (platelet count \<50,000), hypercoagulability, and history of recurrent deep vein thrombosis not related to av access. * subjects with active malignancy. * subjects with a history of poor compliance with the dialysis protocol. * subjects with a known or suspected allergy to any of the device materials. * subjects with an existing fistula or graft. * subjects who are anticipated to convert to peritoneal dialysis or undergo a transplant within 6 months. * subjects who are pregnant, planning on becoming pregnant, or are breast feeding.
aerosolized colistin to mechanical ventilated patients with pneumonia

Conditions: Pneumonia, Bacterial

Summary: the purpose of this study was to determine the effect of aerosolized colistin on to ventilated patients with carbapenem-resistant gram negative bacteria pneumonia. we hypothesize that adjunct aerosolized colistin, which achieve high drug concentrations in the airway, would more effectively treat the penumbra.

to treat respiratory infection of patients with mechanical ventilation, greater systemic antibiotic dose is required through the patient's venous injection. in this trial, patients with arbapenem-resistant gram negative bacteria pneumonia (crgnb)were assigned to adjunct aerosolized colistin delivered by a jet nebulizer or a vibrating mesh nebulizer comparing to or standard intravenous injection by a randomizing protocol. need for a systemic antibiotic was determined by the clinical physician. comparisons were made between standard care and study drug for their effects on bacteria eradiation, incidence of nephrotoxicity, and oxygenation.

Eligibility criteria:
inclusion criteria: * patients received invasive mechanical ventilation \>48 hours * diagnosed with pneumonia caused by carbapenem resistance gram negative bacteria exclusion criteria: * pregnant or lactating women * receiving colistin \> 3 days * recurrent pneumonia caused by carbapenem resistance gram negative bacteria * allergy to colistin or polymyxin b drugs * immunocompromised, defined as neutropenia anc\<500 cells/ul * hiv positive * received chemotherapy with 3 months * renal function deficiency (creatinine clearance \< 30 ml/min)
mt2021-08t cell receptor alpha/beta depletion pbsc transplantation for heme malignancies

Conditions: Hematologic Malignancy; Acute Leukemia; Remission; Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia; AML; TP53; Intrachromosomal Amplification of Chromosome 21; Cytogenetic Abnormality; CNS Leukemia; Minimal Residual Disease; Myelodysplasia; Juvenile Myelomonocytic Leukemia; Somatic Mutation; PTPN11 Gene Mutation; N-RAS Gene Amplification; Neurofibromatosis 1; NF1 Mutation; CBL Gene Mutation; Monosomy 7; Chromosome Abnormality; Fetal Hemoglobin

Summary: this is a phase ii, open-label, prospective study of t cell receptor alpha/beta depletion (α/β tcd) peripheral blood stem cell (pbsc) transplantation for children and adults with hematological malignancies


Eligibility criteria:
inclusion criteria: * histological confirmation of hematological malignancies * acute leukemias * acute myeloid leukemia (aml) and related precursor neoplasms * favorable risk aml is defined as having one of the following: * acute lymphoblastic leukemia (all)/lymphoma * myelodysplasia (mds) ipss int-2 or high risk (i.e. raeb, raebt) or refractory anemia with severe pancytopenia, transfusion dependence, or high risk cytogenetics or molecular features. * age 60 years of age or younger at the time of consent * karnofsky performance status ≥ 70% or lansky play score 50% for ≤16 years of age. * adequate organ function exclusion criteria: * pregnant or breastfeeding. * active uncontrolled infection within 1 week of starting preparative therapy * known seropositive for hiv or known active hepatitis b or c infection with detectable viral load by pcr. * any prior autologous or allogeneic transplant * cml blast crisis * active central nervous system malignancy

Keywords: bu flu g-csf gfsr agvhd hct mac mel pbsct ptld recist tcr
bird watching to reduce stress in university students

Conditions: Stress, Psychologic

Summary: the goal of this study is to learn if birdwatching can reduce stress in university students. it will also explore students\&#39; experiences with the intervention. the main questions it aims to answer are: does birdwatching reduce students\&#39; perceived stress levels? what are the experiences of students who participate in the birdwatching intervention? why do some students drop out of the study? researchers will compare a group of students who participate in birdwatching outings to a control group that does not receive the intervention to determine if birdwatching is effective in reducing stress. participants will: either participate in birdwatching outings or be in a control group with no intervention complete a perceived stress scale (pss-10) to measure their stress levels take part in semi-structured interviews to discuss their experiences with the intervention or their reasons for dropping out of the study


Eligibility criteria:
inclusion criteria: * university students who meet the following inclusion criteria will be included in the study: being 18 years of age or older, being enrolled in any undergraduate program at the universidad industrial de santander, having a score of 10 or higher on the perceived stress scale (pss-10), and having access to whatsapp. exclusion criteria: * university students with a medical diagnosis of any mental illness under pharmacological or non-pharmacological treatment, with health conditions that prevent them from seeing, hearing, or moving, as well as students who have engaged in birdwatching in the last six months, will not be included.
open-label access protocol of denosumab for subjects with advanced cancer

Conditions: Bone Metastases in Men With Hormone-Refractory Prostate Cancer; Bone Metastases in Subjects With Advanced Breast Cancer

Summary: this trial will facilitate access to denosumab for adults with advanced cancer who have participated in a denosumab phase 3 study until denosumab is approved and available for sale.


Eligibility criteria:
inclusion criteria: * subject was previously enrolled in a denosumab phase 3 study and participated in the open-label extension portion of that study. * subject or subject's legally acceptable representative has provided informed consent. exclusion criteria: * subject is of child bearing potential and planning to become pregnant within 7 months after the end of treatment. * subject is of child bearing potential and is not willing to use, in combination with her partner, two highly effective methods of contraception during treatment and for 7 months after the end of treatment. * subject has known sensitivity to any of the products to be administered during dosing. * subject will not be available for protocol required study visits or procedures, to the best of the subject and investigator's knowledge. * subject has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures.

Keywords: cancer bone metastases breast cancer prostate cancer
comparison of different subsequent treatments after radical surgery

Conditions: Cervical Cancer

Summary: cervical cancer is still the most common gynecologic cancer. there was no obvious increase of the survival over years. the risk of recurrence after radical surgery has increased with positive lymph nodes, positive surgical margins, positive lymphatic vascular space and deep invasion of the cervical stroma. in recent years, the role of chemotherapy for cervical cancer has been gradually recognized. but as a adjuvant therapy post-surgery, if chemotherapy can improve the overall survival rate of patients with adverse pathological prognostic factors is inconclusive. in this study, in order to investigate the effect and adverse reaction of chemotherapy as the adjuvant therapy post-surgery on patients with adverse pathological prognostic factors, nine hundred and ninety patients will be randomly divided into three groups, comparing radiotherapy alone, concurrent chemoradiation and sequence chemotherapy and radiotherapy (2 cycles chemotherapy of paclitaxel and cisplatin before and after the irradiation). the investigators aim to find out the best therapeutic regimen with lowest adverse reaction for cervical cancer with adverse pathological prognostic factors. to guide clinical treatment options.

after radical surgery, patients with stage ib1 to iia2 cervical cancer who had one or more following pathological factors were recruited: lymph node metastases (lnm), positive parametrium or margins (ppm), lymphatic vascular space involvement (lvsi), deep invasion of cervical stromal (dis). eligible patients were randomized to three groups. group a underwent 50 gy rt alone. group b received concurrent weekly cisplatin and rt. group c received paclitaxel and bolus cisplatin every three weeks for two cycles before rt, followed by two cycles. we have recruited 800 patients till november 2014.

Eligibility criteria:
inclusion criteria: * patients with newly histologically confirmed cervical carcinoma * original clinical stage must be ib\~iia （figo） * age between 18-65 * with the presence of these four factors after radical surgery:(1)positive lymph nodes,(2)positive parametria, or positive surgical margins,(3)positive lymphatic vascular space,(4)outer one-third invasion of the cervical stroma * more than 3 months survival is to expect * patients must give signed informed consent exclusion criteria: * the presence of uncontrolled life-threatening illness * receiving other ways of anti-cancer therapy * residual tumor which can not be removed in the surgery * investigator consider the patients can't finish the whole study * with normal liver function test (alt、ast\>2.5×uln) * with normal renal function test (creatinine\>1.5×uln) * wbc\<4,000/mm3 or plt\<100,000/mm3 * receive the external pelvic irradiation before the surgery

Keywords: cervical cancer concurrent chemoradiation randomized controlled clinical trials
open-label study to evaluate safety and efficacy of ccx168 in subjects with iga nephropathy on stable raas blockade

Conditions: Immunoglobulin A Nephropathy

Summary: the primary safety objective of this study is to evaluate the safety and tolerability of ccx168 in subjects with igan on background supportive therapy with a maximally tolerated dose of raas blockade. the primary efficacy objective is to evaluate the efficacy of ccx168 based on an improvement in proteinuria.

study acquired by amgen and all disclosures were done by previous sponsor chemocentryx.

Eligibility criteria:
key inclusion criteria: * diagnosis of immunoglobulin a nephropathy * estimated glomerular filtration rate \>60 ml/min/1.73 m2 * proteinuria (first morning urinary protein:creatinine ratio \>1g/g creatinine) key exclusion criteria: * severe renal disease * pregnant or nursing * proteinuria \>8g/g creatinine or \>8g/day * systemic manifestations of henoch-schonlein purpura within 2 years prior * patients with immunoglobulin a nephropathy deemed secondary to underlying disease * biopsy reported severe crescentic immunoglobulin a nephropathy * history of treatment with glucocorticoids, cyclophosphamide, azathioprine, mycophenolate mofetil, or any biologic immunomodulatory agent with 24 weeks prior * history of clinically significant cardiac conditions * history of cancer within 5 years prior * any infection requiring antibiotic treatment that has not cleared prior to study start
a safety and efficacy study of e10030 (anti-pdgf pegylated aptamer) plus lucentis for neovascular age-related macular degeneration

Conditions: Age-Related Macular Degeneration

Summary: the objectives of this study are to evaluate the safety and efficacy of e10030 intravitreous injection when administered in combination with lucentis® against a control of lucentis® alone in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration (amd).

subjects will be randomized in a 1:1:1 ratio to the following dose groups: * e10030 0.3 mg/eye + lucentis® 0. 5 mg/eye * e10030 1.5 mg/eye + lucentis® 0. 5 mg/eye * e10030 sham + lucentis® 0. 5 mg/eye subjects will be treated with active e10030 or sham e10030 in combination with lucentis® at day 0, week 4, week 8, week 12, week 16 and week 20. primary efficacy endpoint: the primary efficacy endpoint is mean change in visual acuity from baseline at the week 24 visit safety endpoints: safety endpoints include adverse events, vital signs, ophthalmic variables \[visual acuity, intraocular pressure (iop), ophthalmic examination, color fundus photography, fluorescein angiograms (fa), optical coherence tomography (oct)\], and laboratory variables. approximately 444 subjects will be randomized into one of the three treatment cohorts (approximately 148 patients per dose group).

Eligibility criteria:
inclusion criteria: * subfoveal choroidal neovascularization (cnv) due to amd exclusion criteria: any of the following underlying diseases including: * diabetes mellitus * history or evidence of severe cardiac disease (e.g., nyha functional class iii or iv - see appendix 19.6), history or clinical evidence of unstable angina, acute coronary syndrome, myocardial infarction or coronary artery revascularization within 6 months, or ventricular tachyarrhythmias requiring ongoing treatment. * clinically significant impaired renal or hepatic function. * stroke (within 12 months of trial entry). * any major surgical procedure within one month of trial entry. * known serious allergies to the fluorescein dye used in angiography (mild allergy amenable to treatment is allowable), to the components of the ranibizumab (lucentis) formulation, or to the components of the e10030 formulation
impact of tramadol and oxycodone on sleep apnea

Conditions: Sleep Apnea

Summary: postoperative pain is usually treated with opioids. among them, oxycodone is popular in the daily practice as it is administered orally and is easily titrated. however, side-effects include increase duration and frequency of apneic episodes. some authors believe that tramadol has less impact on these apneic episodes during the first postoperative night, based on a trial that reported conclusive results only during the first 2 postoperative hours. the objective of this randomized controlled trial is to compare the effect of postoperative pain treatment of oxycodone with tramadol on apneic episodes during the first and third postoperative nights.


Eligibility criteria:
inclusion criteria: * patients scheduled for orthopaedic surgery on the lower limb under a spinal anaesthesia * physical status i-iii exclusion criteria: * planned surgical duration more than 3 hours * contraindication to spinal anaesthesia * severe respiratory disease * patient treated for sleep apnea syndrome * allergy to tramadol or oxycodone
a study of respiratory muscle strength in patients with late-onset pompe disease (lopd)

Conditions: Late-onset Pompe Disease

Summary: study 701-201 is a study in patients with late-onset pompe disease (lopd). the study will test respiratory muscle strength initially and again after 24 weeks in subjects treated or not treated with bmn 701 .


Eligibility criteria:
inclusion criteria: * willing and able to provide written informed consent, after the nature of the study has been explained, and prior to any study-related procedures * documented diagnosis with late-onset pompe disease - at least 18 years of age at study entry * willing and able to comply with all study procedures exclusion criteria: * requires ventilatory support while awake and in the upright position * concurrent disease, medical condition, or extenuating circumstance that, in the opinion of the investigator, might compromise patient well-being, study completion, or data collection * allergy to tools or procedures used for respiratory muscle testing